Intercept Pharmaceuticals suffered another major clinical setback, as its experimental drug INT-787 failed a Phase 2 trial in patients with severe alcohol-associated hepatitis. The drug developer reported that the FXR agonist showed "no clear evidence of potential" in the study, dealing a blow to its pipeline.
This failure represents the latest disappointment for the Italian-owned biotech, which has been attempting to rebound after previous struggles. The company had hoped INT-787 would build on the mechanism of its earlier FXR agonist, Ocaliva, which faced its own regulatory and commercial challenges.
The mid-stage trial was evaluating INT-787 as a treatment for severe alcohol-associated hepatitis, a condition with limited therapeutic options. According to Endpoints News, the study did not meet its efficacy endpoints, and the company has not disclosed detailed data.
Intercept now faces an uncertain path forward, with its pipeline narrowed significantly. The company may need to reassess its R&D strategy or seek new assets to restore investor confidence. The stock is likely to come under pressure following the announcement.
Analysts had tempered expectations for INT-787 given the historical difficulty of developing treatments for alcohol-associated hepatitis, but the complete lack of efficacy signal remains a harsh outcome.